PRINCETON, N.J., Aug. 10 Pharmasset, Inc. (Nasdaq: VRUS), a clinical stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections, today reported financial results and operational highlights for the fiscal quarter ended June 30, 2009.
Revenues were $10.5 million during the quarter ended June 30, 2009 compared to $0.5 million for the quarter ended June 30, 2008 and reflect the receipt of a $10.0 million milestone payment from Roche, following the initiation of the phase 2b study with RG7128, and the amortization of up-front and subsequent collaborative and license payments received from Roche.
Net cash used in operating activities was $5.8 million for the quarter ended June 30, 2009 as compared to $12.7 million for the quarter ended June 30, 2008. Pharmasset held $72.7 million in cash and cash equivalents at the end of the fiscal third quarter.
Total operating expenses for the quarter ended June 30, 2009 were $16.7 million as compared to $15.0 million for the same period in 2008. The increase in operating expenses for the quarter ended June 30, 2009 was primarily the result of an increase in clinical development expenses for PSI-7851, our second generation hepatitis C virus (HCV) product candidate, and preclinical development expenses for our purine series of compounds. Partially offsetting these increases were reduced expenses for our clevudine Phase 3 registration studies that were terminated during the quarter.
Pharmasset reported a net loss of $6.9 million, or $0.25 per share, for the quarter ended June 30, 2009, as compared to a net loss of $15.0 million, or $0.69 per share, for the quarter ended June 30, 2008.
-- On July 31, 2009, Pharmasset announced positive preliminary results from a 3 day, multiple ascending dose trial with PSI-7851, a second generation, nucleotide analog inhibitor in HCV patients;
-- On July 7, 2009, Pharmasset announced the nomination of PSI-938 as a development candidate from two series of purine analogs for the treatment of chronic HCV infection. PSI-938 is a proprietary nucleotide analog polymerase inhibitor of HCV that is being advanced into studies required for submission of an Investigational New Drug (IND) application with the FDA or equivalent foreign regulatory application;
-- On June 9, 2009, Pharmasset announced that it had completed a single ascending dose trial with PSI-7851 and had begun dosing in a 3 day, multiple ascending dose trial in hepatitis C infected patients;
-- On April 25, 2009, Pharmasset announced positive results from the INFORM-1 study of the combination of RG7128 and another oral antiviral medicine, in the absence of interferon and ribavirin, for the treatment of HCV patients; and
-- In the third quarter, Pharmasset received a $10 million milestone from Roche following the initiation of the Phase 2b trial with RG7128, a first generation nucleoside prodrug for the treatment of hepatitis C.
"Pharmasset had another productive quarter, as we continued to make progress on all three of the nucleoside/tide analogs comprising our current portfolio of HCV product candidates", stated Schaefer Price, President and Chief Executive Officer. "We believe HCV therapy is evolving toward combinations of oral antiviral drugs. While we believe combinations of a nucleoside/tide with a drug having a different mechanism of action are very promising, we also believe combinations of two complementary nucleoside/tides have the potential for both a superior resistance profile and activity across all genotypes based on the in vitro evidence to date."
Calendar Year 2009 Anticipated Milestones:
-- Provide an update on safety from the first 100 patients in the Phase 2b trial of RG7128 in second half of 2009;
-- Report additional phase 1 antiviral data with PSI-7851 in second half of 2009;
-- Report further data from the INFORM-1 trial in fourth quarter of 2009.
Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is on the development of oral therapeutics for the treatment of hepatitis C virus (HCV) and, secondarily, on the development of Racivir(TM) for the treatment of human immunodeficiency virus (HIV). Our research and development efforts focus on nucleoside/tide analogs, a class of compounds which act as alternative substrates for the viral polymerase, thus inhibiting viral replication. We currently have three clinical-stage product candidates. RG7128, a nucleoside analog for chronic HCV infections, is in a Phase 2b clinical trial in combination with Pegasys(R) plus Copegus(R) and is also in INFORM-1 studies, the first series of studies designed to assess the potential of combinations of small molecules without Pegasys(R) and Copegus(R) to treat chronic HCV. These clinical studies are being conducted through a strategic collaboration with Roche. Our other clinical-stage candidates are PSI-7851, an unpartnered next generation HCV nucleotide analog which recently began Phase 1 clinical studies, and Racivir, for the treatment of HIV, which has completed a Phase 2 clinical trial.
Pegasys((R)) and Copegus((R) )are registered trademarks of Roche.
Pharmasset "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding our business that are not historical facts are "forward-looking statements" that involve risks and uncertainties, including without limitation, the risk that adverse events could cause the cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies involving our product candidates will not be repeated or observed in ongoing or future studies involving our product candidates, the risk that our collaboration with Roche will not continue or will not be successful and the risk that any one or more of our product candidates will not be successfully developed and commercialized. For a discussion of these risks and uncertainties, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section of our Annual Report on Form 10-K for the fiscal year ended September 30, 2008 and our Quarterly Report on Form 10-Q for the period ended June 30, 2009 filed with the Securities and Exchange Commission entitled "Risk Factors" and discussions of potential risks and uncertainties in our subsequent filings with the Securities and Exchange Commission.
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SOURCE Pharmasset, Inc.